ESMO 2022 PRESTO: A Phase III, Open-Label Study of Enhanced Androgen Deprivation Therapy in Patients with High-Risk Prostate Cancer

Abstract number: LBA63

：PRESTO:：A phase III, open-label study of androgen annihilation in patients (pts) with high-risk biochemically relapsed prostate cancer (AFT-19)

In patients with biochemically recurrent prostate cancer (BRPC) after radical prostatectomy (RP), the prostate-specific antigen multiplication time (PSADT) is short, and the incidence of distant metastases and prostate cancer-specific deaths is high

RESTDO is a randomized, open-label Phase III clinical trial of BRPC, PSADT ≤ 9 months in patients without distant metastases on routine imaging (NCT03009981

Figure 1 Technology roadmap

A total of 504 patients were randomly divided into ADT alone (N=167), ADT+APA (N=168), and ADT+APA+AAP (N=169).

Figure 2 bPFS analysis of ADT+APA treatment group and ADT group

Figure 3 bPFS analysis of ADT+APA+AAP treatment group and ADT group

The median TTTR in the ADT group, ADT+APA group, and ADT+APA+AAP group was 3.
9, 3.
8, and 4.
7 months
, respectively.

The MFS and TTCR results are shown in Figures 4 and 5
.

Figure 4 Analysis of three groups of MFS results

Figure 5 Analysis of three sets of TTCR results

The most common grade 2 or higher adverse events (AEs) were hypertension (19.
4% in the ADT group; ADT+APA group 23.
4%; ADT+APA+AAP group 30.
4%)
.

Of all treatment groups, 8 patients (1.
8%) discontinued treatment
due to AEs.

Combining APA on the basis of ADT can achieve a more comprehensive AR blocking effect, which has the advantages
of prolonging bPFS, safe and controllable, and not affecting TTTR in a limited treatment time.

But more hypertensive events
were observed in the treatment group with AAP.

In summary, enhanced ADT therapy
can be applied in high-risk BRPC patients.

Reference source:

Wang Mumu

Reviewer: LR

Execution: Small Garden